A Study of the Once Daily Combination of Etravirine and Darunavir/Ritonavir As Dual Therapy in Early Treatment-Experienced Patients
Public ClinicalTrials.gov record NCT01199939. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Single Arm, Open-Label Study of the Once Daily Combination of Etravirine and Darunavir/Ritonavir As Dual Therapy in Early Treatment-Experienced Patients
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is a Phase II single arm, open-label, multicenter, study of 50 human immunodeficiency virus-1 (HIV) infected adult patients, all of whom will receive etravirine (ETR) 400mg and DRV/r 800/100mg each given orally once daily. This trial is designed to evaluate the efficacy of the aforementioned ARV regimen, as measured by the percentage of patients with HIV RNA \<50 copies/mL at 48 weeks, in early treatment-experienced HIV-infected patients. In addition to general safety parameter measurements, this trial will also assess changes in metabolic, inflammatory, immune restoration, and bone markers. Screening will occur over a 6-week period. The primary endpoint will be assessed at Week 48, and the treatment period is 48 weeks. The end of study endpoint will be met by either completing the Week 48 visit, or by early termination from the study for any reason.
Study identification
- NCT ID
- NCT01199939
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 54 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 2010 (Type not available)
- Primary completion
- Oct 2012 (Actual)
- Completion
- Oct 2012 (Actual)
- Last update posted
- Dec 4, 2013
2010 – 2012
United States locations
- U.S. sites
- 22
- U.S. states
- 12
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Long Beach | California | — | — |
| Not listed | Los Angeles | California | — | — |
| Not listed | San Francisco | California | — | — |
| Not listed | Denver | Colorado | — | — |
| Not listed | Washington D.C. | District of Columbia | — | — |
| Not listed | Ft. Pierce | Florida | — | — |
| Not listed | Miami | Florida | — | — |
| Not listed | Orlando | Florida | — | — |
| Not listed | Decatur | Georgia | — | — |
| Not listed | Macon | Georgia | — | — |
| Not listed | Berkley | Michigan | — | — |
| Not listed | St Louis | Missouri | — | — |
| Not listed | Hillsborough | New Jersey | — | — |
| Not listed | Neptune City | New Jersey | — | — |
| Not listed | Buffalo | New York | — | — |
| Not listed | Manhasset | New York | — | — |
| Not listed | Charlotte | North Carolina | — | — |
| Not listed | Austin | Texas | — | — |
| Not listed | Dallas | Texas | — | — |
| Not listed | Harlingen | Texas | — | — |
| Not listed | Houston | Texas | — | — |
| Not listed | Seattle | Washington | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01199939, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 4, 2013 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01199939 live on ClinicalTrials.gov.